Z-2308-2021Class II

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic...

Name: Z-2308-2021 Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic...
Creator: Hitachi Healthcare Americas Corporation
Published: 2021-06-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-06-30 / Open, Classified / root cause: sterility

FDA source

Hitachi Healthcare Americas Corporation began a recall of Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures on 2021-06-30. FDA classified it as Class II and gives the reason as "The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2308-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-30
Posted: 2021-08-16
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Hitachi issued Urgent Medical Device Correction Letter to customers on 6/30/2021 using FedEx (with tracking). Letter states reason for recall, health risk and action to take: Customers/Users are advised to: 1. Remember to thoroughly inspect the probe before and upon completion of your cleaning and sterilization process and before and after any interoperative procedure as indicated in the Cleaning, Disinfection and Sterilization Instruction Manual including verifying the 2 screw covers are not loose, damaged, dislodged, or missing. 2. If any abnormalities exist, immediately remove the probe from service and contact Hitachi Customer Service at 1-800-800-4925. 3. Please complete the attached Medical Device Recall Return Response Form and return to Hitachi at your earliest convenience. Type of Action by the Company: An updated manual is included with newly manufactured L43K probes to include the above diagram for additional clarification. (7) Other Information: For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email [email protected]
Quantity in commerce: 120 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Serial Numbers: 20504835, 20504836, 20504837, 20504838, 20504839, 20556338, 20556369, 20556370, 20615320, 20615321, 20639217, 20639218, 20639219, 20639223, 20639224, 20639225, 20639226, 20639230, 20665290, 20693154, 20693155, 20693156, 20693157, 20693158, 20693159, 20693160, 20693161, 206E0051, 206E0058, 206E0059, 203R8980, 203R8981, 203R8986, 203R8987, 203R8988, 203R9022, 203R9023, 203R9031, 203R9032, 203R9033, 203R9034, 203R9035, 203R9036, 203R9037, 203R9038, 203R9041, 203R9042, 203R9047, 203R9048, 204J8480, 204J8481, 204J8482, 204J8483, 204J8484, 204Q3434, 204Q3435, 204S3741, 204S3742, 204S3746, 204S3747, 204S3755, 204S3757, 204S3758, 204S3759, 204S3760, 204S3773, 204U7420, 205B5697, 205B5703, 205B5713, 205F1090, 205F1091, 205F1092, 205F1093, 205F1095, 205F1097, 205F1109, 205F1110, 205F1119, 205Q9088, 205Q9089, 205Q9090, 205Q9091, 205Q9099, 206G6141, 206G6149, 206G6150, 206G6151, 206G6152, 206G6153, 206G6154, 206G6155, 206G6156, 206G6157, 206G6158, 206G6164, 206G6166, G3002072, G3002073, G3002074, G3002076, G3002077, G3002078, G3002079, G3002080, G3002081, G3002082, G3002083, G3002084, G3002086, G3002087, G3002088, G3002089, G3002090, G3002091, G3009910, G3009911, G3009972, G3009973, G3009974, G3020256, G3020257, G3020265, G3020270, G3020271, G3020276, G3020282, G3020283, G3020284, G3020285, G3020286, G3020287, G3020288, G3020289, G3020290, G3020291, G3020292, G3020293, G3020294, G3042776, G3054934, G3054935, G3056539, G3056540, G3056541, G3056542, G3056543, G3056544, G3056545, G3056546, G3056547, G3056548, G3056549, G3056550, G3056551, G3056552, G3056555, G3072337, G3072338, G3072339, G3072340, G3072341, G3072364, G3073380, G3079843

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2308-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2308-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-25	2021-08-16

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)